Advocates for Bayh-Dole make a great deal over the number of drugs that involve university patents that have been approved since the passage of the Bayh-Dole Act. One of their measures is the number of drugs that have been developed. But there’s a catch–not only are many of the drugs outrageously priced, but the sad fact is, many of those high-priced drugs don’t actually provide much benefit in exchange for the suffering they cause. Let’s have a look-see.
$1.3 trillion in economic output. Support for roughly 4.2 million jobs. The creation of more than 11,000 start-up companies. More than 200 new drugs and vaccines. This is the legacy of the Bayh-Dole Act, which for more than 35 years has empowered universities, small businesses and non-profit institutions to take ownership of innovations discovered through basic federally-funded research.
Here is Joe Allen, the Al Gore of Bayh-Dolism:
The successful integration of public research institutions into the economy is based on the Bayh-Dole Act, which inserted the incentives of patent ownership into the government R&D system. Not a single new drug had been developed from NIH funded research under the patent destroying policies preceding Bayh-Dole.
These folks don’t even attempt to show which of these drugs actually involved subject inventions–inventions made with federal support and thus subject to the standard patent rights clauses authorized by Bayh-Dole. Instead, we are to believe by association–that the number of new drugs that involve university inventions is somehow an indication of the success of the Bayh-Dole Act, and we should accept then most everything else that has been done in the name of Bayh-Dole without question–compulsory ownership policies at universities, refusal of universities to comply with the standard patent rights clause, indifference at key federal agencies to enforcing the standard patent rights clause or practicing the inventions licensed to the government.
The BIO folks have no foundation for their claims about job creation–their big number is apparently just the output of a model that multiplies smaller numbers based on licensing income and typical royalty rates. Gibberish and nonsense, but for a political purpose. Joe Allen’s claim that “not a single drug had been developed” is also nonsense–Cisplatin, Joe–but perhaps Allen has his fingers crossed and means something narrow by “patent destroying policies,” something that he doesn’t bother to attempt to communicate. You know how politics is–it’s about bluffing and lying. No one expects the truth, so it’s okay to bluster. Why should we expect truth here? Why should we bother with the truth when we are dealing with research to cure diseases that cause such horrible suffering? Winning at politics is apparently so much more important, because winning at politics means getting billions of dollars in federal subsidies.
Think about it: if we have a law with the primary attributes that it:
Compels institutional ownership of all inventions regardless of the capabilities of the institutions to manage those inventions
Allows the institutions to ignore the key provisions of the law and its implementing regulations
Allows federal agencies to be indifferent to compliance with the law
Allows federal agencies to ignore the rights to practice inventions obtained under the law
Would you think that the law was a good law? That what was happening was a result of the law? If folks aren’t complying with the law, and the law isn’t being enforced, and the government isn’t using the rights it has negotiated for, then it’s clear that whatever is happening is not the result of the operation of Bayh-Dole.
The standard of success set out in Bayh-Dole is that of “practical application” of subject inventions. Practical application means demonstrated use of the invention such that the benefits of the use are available to the public on reasonable terms.
demonstrated use public benefits reasonable terms
The metrics of success, then, must involve demonstration of use, an account of public benefits, and a showing that the terms of those public benefits are reasonable. The number of inventions reported and the number of patent applications filed or patents issued has nothing to do with it. For each invention that becomes a subject invention, show that the patent system has been used to promote practical application–that is, make practical application more widespread and beneficial than would happen otherwise, and show that the terms are reasonable.
For such a demonstration, the metrics must be public. We must see that each invention is being used, we must see the public benefits–how can they be public benefits if they aren’t public?–and we must see the terms on which those benefits are made available. But Bayh-Dole is drafted to make it appear that reports on invention use must be kept secret by the government–and the government doesn’t have to even request those reports. And the government doesn’t appear to check the completeness or even the accuracy of the reports. It’s clear that there is no public evidence that supports the idea that Bayh-Dole has been a roaring success. The proxy metrics that are put forward–number of inventions reported, number of licenses, and the like–have nothing to do with it. These metrics don’t even break out which inventions are subject inventions. Nor do they indicate use with public benefits on reasonable terms. Instead, they show the extent of institutional claims on inventive work, the placing that inventive work behind a paywall, where it is kept from use until licensed–and the vast majority of inventions are not licensed–and licenses, where exclusive, merely extend and deepen the exclusion to general practice of the invention.
An exclusive license (often an assignment of the underlying invention) creates a private monopoly. That’s the effect of Bayh-Dole–taking inventions from inventors, handing those inventions to institutions, and then encouraging those institutions to create new private monopolies that exclude all others (even the inventors and investigators, if they leave their university) from practicing the invention. So far, these metrics count against practical application.
Only if the result of this taking, institutional patenting, and private monopolization is practical application do we have some reason to applaud the taking, patenting, and monopolizing.
Let’s go one step further. Let’s look at those drugs that have been commercialized. Consider this: most of these drugs do not cure anything–and often they do not extend survival for a meaningful term, and often they have horrible side effects. According to Travis Christofferson,
The cost for cancer drugs went from an average of about $5,000 before 2000 to $40,000 by 2005, and in 2012, almost every new drug was priced at more than $100,000 in the United States.
That’s the annual cost to a patient–or to the patient’s insurer. More:
The United States spent twice as much as any other country on oncology and medical care in general yet achieved the same survival rate except for breast cancer and lymphoma, where it eked out a 1-2 percent better survival rate.
(See Tripping Over the Truth, 158).
Or consider this report regarding the effectiveness of chemotherapy:
The overall contribution of chemotherapy to 5-year survival was found to be just 2.1% for cancer patients in the U.S. and 2.3% for patients in Australia. While the 5-year cancer survival rate for Australian cancer patients is at this time more than 60%, these studies have shown that the use of chemotherapy makes a negligible contribution.
The cancer drugs contribute a tiny amount to survival rates. This isn’t a cure–it’s robbery on an airplane that’s out of fuel. Extract as much money as you can before the plane crashes–and if possible, prolong the descent to get a few extra years of payment out of the deal.
And consider the adverse effects. Studies of patients who die within 30 days of starting chemotherapy show that anti-cancer drugs can also be anti-life drugs:
For the first time researchers looked at the numbers of cancer patients who died within 30 days of starting chemotherapy, which indicates that the medication is the cause of death, rather than the cancer.
The study by Public Health England and Cancer Research UK found that across England around 8.4 per cent of patients with lung cancer, and 2.4 per cent of breast cancer patients died within a month.
But hey, the drugs get sold and the pharmaceutical companies make money–not so much as they might have counted on if only the patients had held on for a few more months, but profit is profit. It’s this sort of thing that’s packed into the idea that new drugs have been developed and that’s just rosy grand. Drugs that don’t do much good. Drugs that kill off patients. But hey, if Bayh-Dole has created more of these drugs than we would have otherwise, and investors in American pharmaceutical companies have done well, isn’t that the public good that we all crave from university patent licensing?
Or consider side effects, from “Death by Doctoring”:
Vincristine is a commonly applied chemotherapy agent. Its side effects include rapid heartbeat, wheezing or difficulty breathing, skin rash or swelling fever or chills, infection, unusual bleeding or bruising, abdominal or stomach cramps, loss of movement or coordination, muscle spasms, seizures, or convulsions.
Another common drug is Actinomycin-D. The side-effects again are horrendous. They include hair loss, anemia, low white platelet count, nausea, sickness, diarrhea, and liver failure.
What to make of this?
Even the number of new drugs produced under the influence of the Bayh-Dole Act is a meaningless proxy metrics. While there may be some drugs that represent cures, the overall consequence is that those suffering from disease are given false, unreliable, ineffective, and–often–horrible “remedies” for their diseases. The remedies don’t significantly change survival outcomes, don’t cure, don’t do much for certain but raid bank accounts and offer false hope and induce nausea. We return again to the fundamentals:
For how many of these new drugs touted as the result of Bayh-Dole do we have practical application–a beneficial public use on reasonable terms? The answer is: it is not of any interest to those supporting Bayh-Dole to report, nor even to find out. People supporting Bayh-Dole are riding a gravy train, but it is not gravy that provides the public benefit claimed. The so-called patent medicines were a scam. In their new, FDA-regulated form, they still often are. Bayh-Dole is another device planted in federal law to route public research money to private speculation in patent medicines. It doesn’t have to be this way, even with Bayh-Dole, but Bayh-Dole is unenforced, was gutted in 1984, and federal agencies are indifferent to its effects. Horrible.
It’s not just the monster of a law, but also the exploitative creatures that are attracted to it, or at least to the faux version of it. Repeal the law. Chase off the creatures. Find some humans. Try something different that doesn’t involve institutional suppression of opportunities, doesn’t metastasize private monopolies to speculate on public health, doesn’t take pride in producing mostly drugs that drain people’s bank accounts but do little to actually help them.
At least demand the truth in reporting outcomes. At least demand compliance with the law. At least hold university patent administrators accountable for their words and actions, especially when they deal with untruth and lies.